KR20080082673A - Two-sided non-stick release film - Google Patents

Abstract

Assemblies (100) for the adhesive attachment to the skin or mucosa of a host are disclosed. The assembly or transdermal patch includes an outer backing layer (112), a first layer of adhesive (110) on the inner surface of the outer backing layer (112), an inner backing layer (124), and an intermediate release liner (104) between the first layer of adhesive (110) and the inner backing layer (124). The intermediate release liner (104) includes a releasable surface on both its inner and outer surfaces.

Description

Double-sided non-adhesive release film {TWO-SIDED NON-STICK RELEASE FILM}

Cross reference

The present invention claims priority to US patent application Ser. No. 11 / 296,604, filed Dec. 7, 2005, the disclosure of which is incorporated herein by reference.

Technical field

The present invention generally relates to assemblies for attaching adhesive adhesives to the skin or mucous membranes of a host. More specifically, the present invention relates to percutaneous patches and wound bandages and methods of making the same. More specifically, the present invention relates to an improved method of making adhesive patches.

The use of various systems for adhesive adhesion to the skin or mucous membranes of a patient or host is becoming increasingly important. These assemblies may be in the form of wound bandages that contain no active agent at all and are applied directly to the skin or in the form of percutaneous patches for transdermal delivery of various active agents or drug systems in connection with such attachment. With regard to the general means for manufacturing such assemblies, there is an increased need to facilitate handling of adhesive containing assemblies or patches, and then to maintain them as detachable units. With regard to the percutaneous patch system, various drugs are being used in admixture with adhesive-based systems for application to the skin, or in admixture with non-adhesive based systems with other drug penetrant adhesive layers. Problems have arisen by using it.

Simple single transdermal systems incorporate the active agent, i.e., the drug, into one pressure-sensitive adhesive layer. These systems have the advantage of being thin, refined and relatively easy to manufacture, but must compromise the ability of the system to adhere to the skin versus the optimization of the adhesive matrix for drug delivery. In addition, these systems still present problems with large capacity in handling and manufacturing.

Known " double-disk " transdermal patches use larger secondary patches on top of relatively small active agent delivery patches to improve or ensure adhesion to the skin. The adhesive matrices of the inner and outer patches can be independently optimized for active agent delivery and adhesion, respectively. When the inner and outer patches are stacked together to form a finished system, the adhesive matrices of the system are in direct contact to initiate equilibration. Once the system is equilibrated, time-dependent changes such as loss of the active agent from the inner patch occur, and at the same time the active agent accumulates in the outer patch. This phenomenon can change the performance of the percutaneous patch if any of the components in the inner patch, especially those needed to achieve or maintain active agent delivery, have a significant affinity for the outer patch adhesive matrix. Moreover, this effect will become more severe over time until equilibrium is achieved.

One solution to preventing the equilibrium of the two adhesive matrices is to maintain the physical separation of the two matrices and to prevent the adhesives from directly contacting each other during storage. Once applied to the skin, these adhesive matrices are in direct contact, but the equilibrium process is slow compared to the transdermal delivery process, which typically reaches 2-3 years, typically within 7 days. However, in double-disk percutaneous patches, the rim of the inner patch containing the active agent is exposed to the outer patch coated thereon and the adhesive matrix thereof. This structure of the double-disk percutaneous patch allows the active agent to be moved circumferentially from the inner patch into the adhesive matrix of the outer patch.

Solutions to some of these problems are presented in US Patent Publication No. 2005/0037059, to which the assignee of the present application is entitled. This application discloses a method of using a physical barrier between the patches during storage so that movement of the active agent between the inner and outer patches is inhibited. According to this disclosure, the inner and outer patches are glued to each other in a manner that creates an annular flap around the outer portion of the inner patch and a disposable release liner between the adhesive of the annular flap and the outer patch. Is inserted. The outer flap containing the active agent is thus separated from the bottom of the outer part by a release liner detachably attached to the adhesive on the outer patch. Although this product has proved very successful, there remains a need for a product that is more efficient at completely isolating the annular flap containing the active agent from the bottom of the outer patch.

According to the present invention, the above and other objects are an assembly for attaching an adhesive adhesive to the skin or mucous membrane of the host, the outer backing layer comprising an inner surface and an outer surface, the inner back of the outer backing layer A first adhesive layer disposed on a surface, an inner backing layer, and an intermediate release liner disposed between the first adhesive layer and the inner backing layer, the intermediate release liner comprising an inner surface and an outer surface, the intermediate Both the inner surface and the outer surface of the release liner were implemented by finding an assembly that includes a releaseable surface. Advantageously, said intermediate release liner comprises at least one open area and said first adhesive layer comprises a portion bonded to said inner backing layer at said at least one open area.

According to one embodiment of the assembly of the invention, the intermediate release liner comprises a single sheet with a releaseable surface on both sides.

According to another embodiment of the assembly of the invention, the intermediate release liner comprises an activator impermeable material. Preferably, the intermediate release layer is releasably adhered to both the first adhesive layer and the inner backing layer.

According to another embodiment of the assembly of the present invention, the first adhesive layer comprises a pressure sensitive adhesive material for adhering the assembly to the skin or mucous membrane of the host.

According to another embodiment of the assembly of the invention, at least one of the sheet pairs comprises a transparent sheet. Preferably, the other of the sheet pairs comprises an opaque sheet. In a preferred embodiment, the assembly comprises a material printed on the other inner surface of the sheet pair.

According to the present invention, there is provided a system for handling a plurality of adhesive-coated elements, the outer backing layer having an inner surface and an outer surface and a first adhesive layer provided on the inner surface of the outer backing layer. A first adhesive coating material comprising, a second adhesive coating element comprising an inner surface and an outer surface comprising an inner backing layer, an intermediate release installed between the first adhesive layer and the inner backing layer of the second adhesive coating element A system has been found that includes a liner, wherein the intermediate release liner includes an inner surface and an outer surface, and both the inner surface and the outer surface of the intermediate release liner include a releaseable surface. In a preferred embodiment, the intermediate release liner comprises a single sheet with a releasable surface on both sides.

According to one embodiment of the system of the present invention, the intermediate release liner comprises a laminate comprising at least one pair of sheets secured to each other, the sheet pairs each comprising an inner surface and an outer surface, the inner of the sheet pair The surfaces are installed in parallel with each other and the outer surface of the pair of sheets comprises a releaseable surface.

According to another embodiment of the system of the invention, the first and second adhesive coating elements are adapted to include an active agent for release into the skin or mucous membranes of the host.

According to another embodiment of the system of the present invention, the intermediate release liner comprises an activator impermeable material.

According to another embodiment of the system of the present invention, the intermediate release liner is releasably adhered to both the first adhesive layer and the inner backing layer of the second adhesive coating element.

According to another embodiment of the system of the present invention, the first adhesive layer comprises a pressure sensitive adhesive material.

According to another embodiment of the system of the present invention, the releaseable surface of the inner surface of the intermediate release liner has a first release force, and the releaseable surface of the outer surface of the intermediate release liner has a second release force. And the first and second release forces are different from each other.

Thus, the assembly of the present invention not only allows the handling of the multilayer system, but also inhibits the movement of the active agent between the inner and outer patches by maintaining a physical barrier between the inner and outer patches during storage. In fact, the assembly of the present invention prevents the adhesive exposed at the edge of the relatively small adhesive system from adhering to the release film of the relatively large system, thus achieving this result in a more efficient manner than is known so far. In applying the assembly or device of the present invention to the handling of laminated adhesive units, it is clear that the assembly is not limited to a transdermal patch and can be applied to virtually any system in which the active agent is used on the skin or mucous membranes of the host. Accordingly, the present invention contemplates that any component of an assembly, including inert excipients, permeable thickeners, plasticizers, etc., as well as both active and inactive agents and other components, may be used between the inner and outer layers of an adhesive containing assembly such as a patch. The movement can be suppressed extensively.

More specifically, in one embodiment, the assembly or device of the present invention is similar to a dual-disk system that includes an active-containing inner patch permanently attached to the adhesive of the outer patch through an opening provided in the release liner for the outer patch. . The inner patch includes an active agent impermeable backing layer, an active agent layer that contains the active agent for delivery to the skin or mucous membrane of the host, and may be an adhesive matrix layer and a disposable release liner. The outer patch includes a backing layer, an adhesive matrix layer capable of containing additional active agent, and a disposable release liner, preferably of an active agent impermeable material and including a releaseable surface on both the inner and outer surfaces. An opening provided in the release liner of the outer patch exposes a portion of the outer patch adhesive matrix. The opening is smaller in size than the active agent inner patch, providing an anchor point for the inner patch while preventing contact between the inner and outer patches before use.

In one embodiment of the invention, the assembly for releasing the active agent to the skin or mucous membrane of the host, comprising: an outer layer having an adhesive; An inner layer having an active agent impermeable layer, a portion of which is adhered to the outer layer; And a release liner inserted between a portion of the impermeable layer and a portion of the outer layer, wherein removing the release liner exposes the outer layer to adhere the assembly to the skin or mucous membrane of the host. It is.

According to the invention, a plurality of laminated components for the manufacture of an assembly for attaching an adhesive to the skin or mucous membrane of a host, a plurality of first outer backing layers comprising an inner surface and an outer surface, the plurality of outer backings A first adhesive layer disposed on an inner surface of the layer, and a plurality of second intermediate release liners including an inner surface and an outer surface, wherein both the inner and outer surfaces of the plurality of intermediate release liners are releasable surfaces. And as a result, a plurality of components have been devised in which the plurality of first outer backing layers and the plurality of second intermediate release liners can be stacked together without being bonded to one another. In a preferred embodiment, the intermediate release liner comprises a single sheet with a releasable surface on both sides.

According to one embodiment of the laminated plurality of components of the present invention, the intermediate release liner comprises a laminate comprising at least one pair of sheets secured to each other, each pair of sheets comprising an inner surface and an outer surface. In addition, the inner surfaces of the pair of sheets are installed in parallel with each other and each outer surface of the pair of sheets includes a releasable surface.

According to another embodiment of the laminated plurality of components of the present invention, the first adhesive layer comprises a pressure sensitive adhesive material for adhering the assembly to the skin or mucous membrane of the host. In a preferred embodiment, at least one of the sheet pairs comprises a transparent sheet. Preferably, the other of the sheet pairs comprises an opaque sheet. In a preferred embodiment, the assembly comprises a material printed on the inner surface of the other of the sheet pairs.

According to the present invention, there is provided a method of producing an adhesive layer for use in the manufacture of an assembly for attachment to the skin or mucous membrane of a host, the method comprising: coating an adhesive layer on a release liner having a first surface and a second surface, the release liner Laminating a backing layer on the first surface of the substrate, temporarily removing the release liner from the adhesive layer, die cutting the release liner, and attaching the release liner to the backing layer. A method of making an adhesive layer has also been found, comprising the step of recombining, wherein both the first surface and the second surface comprise a releasable surface. Advantageously, said die cutting comprises slitting a release liner into a plurality of release liner sites. In a preferred embodiment, die cutting includes punching an opening in the release liner.

According to one embodiment of the method of the invention, the method comprises drying the coated release liner.

According to another embodiment of the method of the present invention, the method includes removing waste from the adhesive layer.

According to one embodiment of the method of the invention, the method comprises winding the recombined release liner and backing layer in a rolled state.

The subject matter of the present invention is specifically pointed out and specifically claimed in the conclusion of this specification. However, the present invention will be best understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in connection with the characteristics, objects and advantages of the present invention with respect to the solidity and the method of operation.

1 is an exploded perspective view of a non-assembled state of a component of an assembly that releases an active agent for application to a skin or mucous membrane of a host, according to one embodiment of the invention.

FIG. 2 is an assembled cross sectional view of the assembly shown in FIG. 1. FIG.

3 is a plan view of the assembly shown in FIG. 1.

3A is a plan view of another embodiment of a portion of the assembly shown in FIG. 1.

4 is a cross-sectional view to which the assembly shown in FIG. 2 is applied, adhered to the skin or mucous membranes of a host.

5 is an exploded perspective view of a non-assembled state of a component of an assembly releasing an active agent for application to a skin or mucous membrane of a host, according to another embodiment of the present invention.

6 is an assembled cross sectional view of the assembly shown in FIG. 5.

7 is a plan view of the assembly shown in FIG. 6.

8-10 are schematic diagrams illustrating one embodiment of a method of forming an assembly in accordance with the present invention.

11 is an exploded perspective view of a non-assembled state of components for a system for manufacturing a plurality of adhesive containing assemblies.

In describing preferred embodiments of the invention illustrated in the drawings, specific terminology is employed for the sake of clarity. However, it is to be understood that the invention is not limited to the specific terminology so selected, and that each specific term includes all technical equivalents that operate in a similar manner to achieve a similar purpose.

Referring now to the drawings, like reference numerals refer to like elements, and FIG. 1 shows a non-assembled state component of an assembly for administering one or more active agents to the skin or mucous membranes of a host according to one embodiment of the invention. have. Assembly 100 generally includes an outer patch 102, an outer patch release layer 104, an inner patch 106, and an inner patch release layer 108. The outer and inner patches 102, 106, the corresponding release layers 104, 108 are typically planar layers, assembled together to form a laminate composite structure similar to the dual disk assembly described below.

The outer patch 102 includes a flexible adhesive layer 110 and a protective backing layer 112 adhered to and commonly extending therefrom. The adhesive layer 110 provides a primary adhesion of the assembly 100 to the skin or mucous membranes of the host. Preferably, the adhesive layer 110 is a dermatologically acceptable pressure sensitive adhesive suitable for contact with the skin or mucous membranes of the host. Optionally, the adhesive layer can be mixed with an active agent or other drug to be administered to the host. In that case, the adhesive layer 110 will be formed of a material that is active permeable to enable administration of the active agent.

The backing layer 112 is preferably a thin sheet extending in common with the bottom surface of the adhesive layer 110. Because of the area of the skin to which the assembly 100 will be attached, the backing layer 112 may be skin color for cosmetic reasons or may have an identification mark. The backing layer 112 normally provides a support and protective sheath for the assembly 100. The backing layer 112 may be formed of a sheet of an activator impermeable or permeable material. Preferably, the backing layer 112 will be formed of an activator impermeable material when the activator is present in the adhesive layer 110.

The outer patch release layer 104 is protected from loss of activity by ambient dust or other contaminants, both with respect to the adhesive layer 110 and the flexible activator layer 122 and / or adhesive layer 126 of the inner patch 106. The top surface of the adhesive layer 110 is covered prior to using the assembly 100 to provide an active agent migration barrier that will be described while protecting the adhesive layer. The release layer 104 has a sufficient surface area and shape that extends to at least the peripheral edge of the adhesive layer 110. The opening 114 inside the release layer 110 exposes a portion of the top surface of the adhesive layer 110 of the underlying outer patch 102. The release layer 104 may be formed as a single sheet of material or multiple sections 116, 118 separated by one or more slits 120. Preferably, the release layer 104 is formed of an activator impermeable material to provide a barrier to movement for the active agent in both the inner patch 106 and the outer patch 102.

The inner patch 106 includes a flexible activator layer 122 and an activator impermeable backing layer 124 that is commonly attached to and extends from the bottom surface thereof. Active agent layer 122 may be formed from a thermoplastic polymer matrix that is mixed with an active agent or drug component, and optionally an active agent enhancer. The polymer matrix used for the activator layer 122 preferably has pressure sensitive adhesive properties, and alternatively the activator layer may be coated with the activator permeable adhesive layer 126 indicated by dashed lines.

The inner patch release layer 108 is a sheet similar to the release layer 104 and may be formed of one or more sections 128, 130 separated by the slit 132. The release layer 108 has a surface area and shape that extends to at least a peripheral edge of the top surface of the active agent layer 122. The release layer 108 covers the top surface of the active agent layer 122 to prevent release of the active agent prior to use of the assembly 100. When the active agent layer 122 has pressure sensitive adhesive properties or is covered with an active agent permeable adhesive layer, the release layer 108 protects against loss of activity by ambient dust or other contaminants.

The assembly 100 is shown in FIGS. 2 and 3 in a assembled state, generally similar to a laminate composite assembly of a planar layer. The release layer 104 includes releasable surfaces 115 and 117, respectively, and thus in contact with a common extension of the top surface of the adhesive layer 110 of the outer patch 102 and of the active agent permeable backing layer 124. The outer surface is also releasably adhered with respect to all active agents and / or adhesives and / or all other components of the active agent layer 122 and / or adhesive layer 126.

In the case where the release liner 104 comprises a single sheet material, the release coating must be applied to both sides of the release liner 104. Commonly used release coatings include silicone or Teflon coatings or other suitable coatings known in the manufacture of release layers. These coatings can include, for example, fluorocarbon and fluorosilicone coatings that are compatible with silicone-based adhesives.

Opening 114 of release layer 104 exposes a portion of the top surface of underlying adhesive layer 110. The inner patch 106 is adhered to the outer patch 102 by bonding the impermeable backing layer 124 to the adhesive layer 110 exposed in the opening 114. The surface of the opening 114 is less than the surface area of the inner patch 106. This allows the inner patch 106 to have an annular portion similar to the flap surrounding the opening 114, which is not coupled to the adhesive layer 110 due to the inserted portion of the release liner 104. Likewise, the peripheral edges of the activator layer 122 and / or the adhesive layer 126 are separated from the adhesive layer 110 by a portion of the release liner 104. Thus, the presence of a releaseable surface thereon also prevents the active agent, adhesive or other material from adhering to the surface of the release layer 104. Thus, the impermeable backing layer 124 and the impermeable release layer 104 only separate the active agent layer 122 to prevent the active agent from moving from the active agent layer to the adhesive layer 110 during storage of the assembly prior to use. Rather, any adhesive from the adhesive layer 126 moves from the edge of the inner patch 106 and adheres to the pre-release coating surface of the release liner 104, thereby preventing the release liner from being removed before use. To prevent this.

Assembly 100 is manufactured to be applied to the skin or mucous membranes of a host by removal of release layers 104 and 108. In order to facilitate removal of the release layer 104, at least a portion of the release layer preferably extends beyond the perimeter of the underlying adhesive layer 110. The extended portion may be similar to a tab or annular portion surrounding the entire circumference or part of the adhesive layer 110, as shown in FIG. 3. In this manner, each section 116, 118 of the release layer 104 may be removed to expose the top surface of the adhesive layer 110 surrounding the inner patch 106 containing the active agent. The exposed surface portion of the adhesive layer 110 will have sufficient surface area to provide adhesion of the assembly 100 to the skin or mucous membranes of the host during use. Removal of the sections 116, 118 is done separately since the sections are separated by slit 120. This allows the sections 116, 118 to be removed even though a portion of the sections surrounding the opening 114 are inserted between the adhesive layer 110 and the impermeable backing layer 124 of the inner patch 106. do. Most importantly, the presence of releasable surfaces 115 and 117 on both sides of the release liner 104 allows this operation to proceed seamlessly, without disturbing either side or contacting the user's fingers with the adhesive. have.

In the same way, in this case the release layer 108 which requires a releaseable surface on only one side, i.e. the side facing the adhesive layer 126 and / or the activator layer 122, is a section 128, 130. It is removed from the top surface of the activator layer 122 by gripping the extended portion of. Thus, each section 128, 130 of the release layer 108 may have an extension that extends beyond the perimeter of the inner patch 106, and in some cases it is desirable to have such an extension. For example, referring to FIG. 3A, the sections 128, 130 of the inner patch release layer 108 include outer peripheries larger than the perimeter of the inner patch 106, and preferably both ends of the release layer 108. And extended sections 130a and 128a in the form of tabs. In this way, preferably after the outer patch release layer 104 is removed, the inner patch release layer 108 can be removed by holding the tabs 130a and 128a to remove the corresponding section portions 128 and 130. have. Assembly 100 is adhered to the skin or mucous membrane of host 134 with active agent layer 122 in contact with the host, as shown in FIG. 4. The host to which the active agent will be administered using the assembly of the present invention can be any host that can achieve the desired effect by a drug or other active agent. The host can be, for example, a mammal, such as a human, or can be any warm blooded or cold blooded animal. The benefit of administering the active agent may be therapeutic or experimental. Assembly 100 of the present invention may also be used for any other advantageous purpose.

The extended section of release layer 108 may be as described above with respect to FIG. 3A or as described with respect to release layer 104. However, it should be understood that the release layers 104 and 108 need not extend beyond the perimeter of the adhesive layer 110 and the activator layer 122 below, respectively. Extension of the release layers 104, 108 only facilitates the user to remove the release layer before applying the assembly 100.

Individual components of assembly 100 are shown as being rectangular for illustrative purposes only. It is to be understood that assembly 100 and its components may have any other shape, such as square, round, oval, and the like. For example, the outer patch 102 can be square while the inner patch 106 can be circular. In addition, it is not a requirement of the present invention that the opening 114 is rectangular, for example, may be in the form of a polygon such as a hexagon, or may be formed of a plurality of discontinuous openings in the release layer 104. The opening 114 has one function that allows the inner patch 106 to be coupled to the outer patch 102 in assembling the assembly 100. In addition, the surface area of the opening 114 defines the extension of the circumferential portion of the inner patch separated from the adhesive layer 110 by the inserted release layer 104 in relation to the surface area of the inner patch 108. Thus, the size, shape and location of the opening 114 can be adjusted to accommodate the movement of the active agent, for example based on the speed of movement of the active agent within the active agent layer 122. In addition, the size of the opening 114 is between the adhesive layers; That is, it may be utilized to move the active agent from the adhesive layer 110 to the active agent layer 122 and / or the adhesive layer 126 through the opening 114.

5-7, another embodiment of an assembly 136 is disclosed that is intended to administer an active agent to the skin or mucous membranes of a host. The assembly 136 has a shape different from that of the assembly 100 in one side. In this regard, assembly 136 includes a circular outer patch 138, a square or rectangular outer patch release layer 140, a circular inner patch 142 and a circular inner patch release layer 144.

The outer patch 138 includes an adhesive layer 146 and a common extended outer backing layer 148. The adhesive layer 146 can be similar to a pressure sensitive adhesive and can optionally be mixed with an active agent or other drug to be administered to a host. In this case, the backing layer 148 will be similar to a sheet of activator impermeable material.

The release layer 140, like the release layer 104, has a releaseable surface on both sides of the release layer 140, thereby allowing the top and inner patches 142 of the adhesive layer 146 of the outer patch 138 to be released. It is preferably formed from a sheet of activator impermeable material that is releasably adhered to all of the exposed edges of the activator layer 154 (or alternatively the adhesive layer 126). The release layer 140 includes an opening 150 that exposes a portion of the top surface of the adhesive layer 146 through which the inner patch 142 is bonded. Removal of the release layer 140 may be facilitated by a slit 152 extending from the outer edge of the release layer to the opening 150.

The inner patch 142 has an active agent layer 154, which may be a mixture of polymeric materials with the active agent or other ingredients to have pressure sensitive adhesive properties that (at least partially) adhere the assembly 136 to the skin or mucous membranes of the host. Include. That is, the overall ability of the assembly 136 to reliably adhere to the host's skin or mucosa may depend on both the inner patch 142 and the outer patch 138 and the adhesive of the patch. The top surface of the activator layer 154 may be coated with the activator permeable adhesive layer 126, but as in the case of the adhesive layer 126 shown and discussed in FIG. 2, the layer may be excluded and is optional there. . Also, although not shown, it is contemplated that the inner patch 142 may include a rate controlling polymer layer to provide a means for controlling the rate at which the active agent is released from the surface of the inner patch 142 to the skin or mucous membranes of the host. do. The rate controlling polymer layer may be adhered to the surface of the activator layer 154 using any suitable activator permeable adhesive, such as used for the activator layer 154 or the adhesive layer 126.

The inner patch 142 further includes an activator impermeable backing layer 156 adhered to the bottom of the activator layer 154. The impermeable backing layer 156 may utilize the pressure-sensitive adhesive properties of the active agent layer 154 or may be adhered by a layer of an active agent impermeable adhesive, not shown, preferably. The release layer 144, similar to the release layer 108, is applied to the host to prevent release of the active agent before treatment commences, to protect the adhesive properties of the inner patch and to prevent contamination. Releasably adhered to the adhesive layer 126 of the inner patch 142. As such, it can be seen that the release layer 144 only needs one releaseable surface corresponding to the releaseable surface 153 or the releaseable surface 155 on both sides of the release layer 140. Thus, the opposite side of the release layer 144, which is in contact with either the activator layer 154 or the adhesive layer 126 of the inner patch 142, does not come into contact with any surface to be released, thus requiring a releaseable surface. Do not

A portion of release layer 140 is inserted between a portion of the bottom surface of inner patch 142 and the top surface of adhesive layer 146 of outer patch 138. The inner patch 142, the release layer 140, and the outer patch 138 are aligned and overlapped with each other so that the annular portion of the release layer 140 has an outer edge of the inner patch 142 and an inner edge of the release layer opening 150. An assembly inserted between the parts is formed. This annulus separating the outer edge of the inner patch 142 and the inner edge of the opening 150 isolates the active agent layer 154 from the adhesive layer 146 to prevent all active agent (s) from moving therebetween. . Similarly, the presence of the releaseable surface 1534 on the top of the release liner 140 causes the adhesive layer 126 to adhere in an adhesive manner to the surface 153 of the release layer 140. All adhesives, and most particularly adhesives from the exposed edges of the adhesive layer 126. When the release layer 140 is removed, the annular portion of the top surface of the adhesive layer 146 exposes the edge of the inner patch 142 around. Adhesive layer 146 provides sufficient adhesion to adhere assembly 136 to the skin or mucosa of the host. The adhesion of the assembly 136 may optionally be enhanced by bonding the inner patch 142 or the active agent permeable adhesive layer 126 with pressure sensitive adhesive properties.

As described above, the active agent or drug is contained in the active agent layers 122 and 154 and optionally in the adhesive layers 110 and 146. The active agent can be, for example, a systemic or topical drug. Individual active agents or mixtures thereof may be used if necessary. As long as the drug passes through the permeable adhesive layer (s) present, any drug that crosses the skin or mucosa of the host can be used for internal administration in the assembly of the present invention. The active agent and the thermoplastic matrix polymer may be melt-mixed in an extruder and then molded into the active agent layers 122, 154 or the adhesive layers 110, 146 by extrusion. For the incorporation of the active agent, other known methods such as solvent blending can be envisioned.

Suitable systemic drugs for administration by the assembly of the present invention include psychoactive agents such as nicotine, caffeine, mesocarb, mefexamide, cannabinol such as THC, diazepam, mepyridine, uldazepam, tivamate, methacla Sedatives such as zepam and tetrabarbitol, antidepressants such as amitriptyline, imipramine, decipramine, nialamide, melitracene and isocarboxazide, phenobarbitol, carbamazepine, mesuccinimide , Anti-convulsants, such as 2-ethyl-2-phenylmalonamide (PEMA), phenytoin, steroids such as progesterone, testosterone, pregnandiol, progestin, estradiol, anabolic steroids, codeine, morphine, fentanyl, anallopine, Analgesics including anesthetic analgesics such as demeral, analgesics such as acetaminophen, aspirin, sulfonazole, saccanine, silver sulfadiazine, ventiaside And antibacterial agents such as alprazolam and meprobamate, antitumor agents such as sulfosamide and lupochromomycin, and antibiotics such as tetracycline, penicillin and streptoscin.

The amount of active agent present is an amount sufficient to provide a pharmaceutically or physiologically effective rate of administration of the active agent to a host in need thereof. This amount can be readily determined by one skilled in the art without undue experimentation as shown in the examples presented below.

The assemblies 100, 136 of the present invention optionally comprise a rate controlling polymer layer. Polymers suitable for use as the rate controlling polymer layer are conventional in the art and need not be specifically mentioned here. Examples of some preferred materials include polyethylene, polypropylene, ethylene vinyl acetate copolymers (EVA), copolyesters (eg HYTREL) and polyurethanes.

The rate of penetration of the active agent through the rate controlling polymer layer depends on factors such as the affinity of the active agent for the polymer layer, the molecular size of the active agent, the polymer structure of the carrier layer and the thickness of the layer. Thus, the appropriate rate controlling polymer material and its thickness depend on the active agent used and the desired permeation rate. The choice of polymer layer and its thickness provides a means of controlling the rate of administration to the skin or mucous membranes, if desired.

In addition, if there is an active agent layer 122, 154, a rate controlling polymer layer, or an active agent permeable adhesive layer, any one of these layers may include enhancers that promote penetration of the active agent through the skin. The enhancer is incorporated into these layers by solvent blending, or more preferably by melt blending in the same process utilized to incorporate the active agent into either the active agent layers 122, 154 or the adhesive layers 110, 146. The adhesive layer may also include an enhancer.

Suitable enhancers include those described in US Pat. No. 4,573,996, such as the following enhancers: monovalent hatched and unsaturated aliphatic and cycloaliphatic alcohols having 6 to 12 carbon atoms, such as cyclohexanol, lauryl alcohol, and the like; Fatty and alicyclic hydrocarbons such as mineral oil; Alicyclic and aromatic aldehydes and ketones such as cyclohexanone; N, N-di (lower alkyl) acetamides such as N, N-diethyl acetamide, N, N-dimethyl acetamide, N- (2-hydroxyethyl) acetamide, and the like; Aliphatic and cycloaliphatic esters such as isopropyl myristate and laurisidine; N, N-di (lower alkyl) sulfoxides such as decylmethyl sulfoxide; Essential oils; Nitrated aliphatic and alicyclic hydrocarbons such as N-methyl-2-pyrrolidone, azone; Salicylates, polyalkylene glycol silicates; Aliphatic acids such as oleic acid and lauric acid, terpenes such as cineol, surfactants such as sodium lauryl sulfate, siloxanes such as hexamethyl siloxane; And mixtures of the above materials.

The backing layers 124, 156 are substantially incompatible with the layer (s) that may be in contact with, for example, the active agent layers 122, 154, the adhesive layers 110, 146, and the active agent or components contained therein, the adhesive, and the like. It is preferably made of a material or combination of materials that is permeable. In this regard, the primary purpose is to prevent the active agent or components from moving or seeping through the backing layers 124, 156 of the inner patches 106, 142 into the underlying adhesive layers 110, 146. The backing layers 112, 148 may also be made of a similar material that is impermeable to the active agent, especially when the active agent is also present inside the adhesive layers 110, 146. The backing layers 112, 148 need not be impermeable to the active agent, especially when there is no active agent in the adhesive layer 110 146. Thus, in all cases, the backing layers 112 and 148 need not be impermeable to the active agent.

By impermeable, it is meant that other components in contact with the backing layer or components under consideration are not permeable enough to be perceived through such layers or components during normal use and storage of the assembly. Some suitable materials for the backing layer include, for example, cellophane, cellulose acetate, ethyl cellulose, plasticized vinyl acetate-vinyl chloride copolymer, ethylene-vinyl acetate copolymer, polyethylene terephthalate, polyvinyl chloride, nylon, polyethylene , Polypropylene and polyvinylidene chloride (eg SARAN), or combinations / laminates thereof.

Assembly 100, 136 includes a release liner attached to the assembly, such as at a surface to adhere to the skin or mucous membrane of the host. The release liner may be made of the same material that is suitable for backing layer use if it is an active impermeable. Most importantly, the release liners 104 and 140 should include releaseable surfaces on both sides thereof. This allows these release liners to be removable or released from the adhesive layer or active agent layer, for example by conventional treatment with silicone, Teflon or other suitable coatings on their surfaces. Thus, by applying such a coating on both sides of these release liners 104, 140, the objective of easily releasing from the surface of the adhesive layers 110, 146 on the outer patches is achieved, as well as on the inner patches 106, 142. To release from any adhesive or other such material present along, for example, along the outer edge of the inner patch or present on the surface. Removing the assembly 100, 136 from the release liner may also be accomplished by mechanical treatment of the protective layer, for example by embossing the protective liner.

The release liner between the inner and outer patches used in the present invention should include a releaseable surface on both sides thereof, but this can be accomplished in a number of ways. As mentioned above, in embodiments in which a single sheet material is used, a release coating is applied to both sides of the sheet. The release coating may be applied to a single sheet or may modify a conventional release liner with a releaseable surface on one side to include a second release surface on the opposite side. However, in another manner, the release liners 104 and 140 of the present invention can be made from laminates of two or more sheets. For example, in an embodiment in which two sheets are used, a laminate sheet with a release coating on both sides can be made by joining two separate conventional cross-sectional release liner films together. In addition, two uncoated sheets can be bonded to each other, and then a surface that can be released on both outer surfaces can be produced. All of the foregoing provides the manufacturer with additional flexibility to apply various commercially available films or commonly produced release films to one or both of the surfaces simultaneously, or in separate operations.

In either case of a single sheet and multiple sheet release liners 104, 140, in one preferred embodiment of the present invention, they may have the same or different release coatings applied to both sides of the liner itself. Thus, the release characteristics of one or both sides of the release liner can be selectively varied for special purposes. For example, when laminating the coated adhesive on itself, one can predict which bond has a weaker release force or stronger release force to remove. In this way, it is possible to separate the dried film or apply the dried film to a new substrate, for example when constructing multiple laminates from different materials or stacking multiple layers of common adhesive. Therefore, when quantifying a particular release force or distinguishing the release forces on both sides of the release layers 104 and 140, a standard adhesive tape is used in a conventional manner and based on the force required to peel the tape from the release liner. Standard measurement methods can be devised. On the other hand, the peel force required to separate the layers of the finished product can be directly quantified and tabulated if necessary.

In one particular embodiment of the invention utilizing a laminate construction, one layer of the laminate may be a commercially available single-sided release film with a transparent configuration. That is, it is attached to a second laminate, which may be a commercially available film (with or without a release coating), but in this case a colored or opaque release film. In one particular embodiment, for example, a second or opaque release film can be printed on the non-release surface (either before or after applying a release agent, if necessary). In this way, the product obtained is a printed double sided release film where the printing is visible through the release coating on the aforementioned first transparent single sided release film.

Examples of suitable pressure-sensitive adhesive materials used in the present invention as active impermeable adhesives include some natural rubber and synthetic rubber adhesives and crosslinking laminating adhesives. Examples of suitable natural rubber adhesives include B.F. Goodrich Co. Products R-1072, C.L. No. Hathaway products 735 and Evans St. No. Clair 5702 is included. Examples of synthetic rubber adhesives include Jowat Corp. Products include Jowatherem 270-00 and Jowatherem S-3202, and National Starch product 70-9416. Other suitable laminating adhesives include Dow Corning laminating silicone adhesives and Lord Corporation Tycel 7900 series laminating adhesives. Also contemplated are acrylic copolymers such as the trade names DURO-TAK 87-2516 and DURO-TAK 87-2287 available from National Starch and Chemical Co., Bridgewater, NJ. The most impermeable adhesives for most active ingredients are crosslinkable laminating adhesives, which are well known to those skilled in the art.

The active agent permeable adhesive layer is preferably a pressure sensitive adhesive. Any dermatologically acceptable pressure sensitive adhesive that is well known and that can move through the drug can be used in the present invention. Some suitable permeable adhesives include acrylic or methacrylic resins such as polymers of alcohol esters of acrylic acid or methacrylic acid, and n-butanol, isopentanol, 2-methylbutanol, 1-methyl-butanol, 1-methyl- Alcohols such as pentanol, 2-methylpentanol, 3-methylpentanol, 2-ethyl-butanol, isooctanol, n-decanol, or n-dodecanol, alone or copolymerized with ethylenically unsaturated monomers Things such as acrylic acid, methacrylic acid, acrylamide, methacrylamide, N-alkoxymethyl acrylamide, N-alkoxymethyl methacrylamide, Nt-butyl-acrylamide, itaconic acid, vinyl acetate, carbon atoms 10 N-branched alkyl maleamic acid, glycol diacrylate, or a mixture of these monomers having ˜24 individual alkyl groups; Polyurethane elastomers; Vinyl polymers such as polyvinyl alcohol, polyvinyl ether, polyvinyl pyrrolidone, and polyvinyl acetate; Urea formaldehyde resins; Phenol formaldehyde resins, resorcinol formaldehyde resins; Cellulose derivatives such as ethylcellulose, methylcellulose, nitrocellulose, cellulose acetate butyrate and carboxymethylcellulose; And natural gums such as guar, acacia, pectina, starch, estria, gelatin, casein and the like.

Other suitable pressure sensitive adhesives include polyisobutylene pressure sensitive adhesives, rubber pressure sensitive adhesives and silicone pressure sensitive adhesives. The adhesive may also be mixed with tackifiers and stabilizers well known in the art.

Preferred adhesives due to the active agent permeability are acrylic copolymer adhesives such as AS-351 HSX of Avery Chemical Company, and preferably have a coating weight of 75 to 125 g / m 2. This pressure sensitive adhesive is a crosslinkable polymer that provides a permanently tacky film.

Other adhesives that may be used for this purpose include acrylic pressure sensitive adhesives sold under the name DURO-TAK 80-1054 by National Starch and Chemical Co. This adhesive has a solids content of 47.5%, a viscosity of 3,000 cps and a plasticity of 2.9 mm. It is generally used with solvent systems comprising ethyl acetate, heptane, isopropyl alcohol and toluene. Another such adhesive, sold under the trade name GELVA Multipolymer Emulsion 2484 by the UCB Group, includes a stable aqueous acrylic emulsion pressure sensitive adhesive having a solids content of 59% and a viscosity of 1,500-2,300 cps. Examples of other acrylic adhesives include Gelva 788 and 733, C.L. Hathaway PS-41, H.B. Vr-0833 from Fuller, Adcot 73A207A from Morton Chemical, product numbers 80-2404, 80-1054, 72-9056 and 72-9399 from National Starch, product numbers E-2015, E-2067 and E-1960 from Rohm & Haas , M-6112, WR by Uniroyal, Inc. Grace's Daratak 74L. Suitable rubber adhesives include Duro-Tak 36-6172 from National Starch and Morstik 118 from Morton Chemical. An example of a suitable silicone adhesive is 7-4502 from Dow Corning.

The width (ie surface area) and thickness of the permeable adhesive layer to contact the skin or mucosa provide sufficient permeability to the active agent or active agent enhancer, adhere appropriately to the skin or mucosa, and allow for desired dosage rates for the skin or mucosa. Width and thickness to provide a suitable surface area. Such widths and thicknesses are known in the prior art and are not specifically mentioned here.

The activator layers 122 and 154 are preferably monolithic polymeric activator carrier layers. Thus, essentially these monolithic active carrier carrier layers are mixed with the active agent or drug component or active agent enhancer, or both, by melt blending and basically comprise a thermoplastic polymer matrix. However, one can think of a monolithic polymer matrix carrier layer in which the active agent is blended with the matrix polymer in a common solvent and then the solvent is evaporated to form a plastic film. As will be readily appreciated by those skilled in the art, the step of melt blending requires the use of a thermoplastic polymer, ie a polymer that softens and melts when exposed to heat and then returns to its original state when cooled. Suitable thermoplastic matrix polymers are thermoplastic polyurethanes, including polyether polyurethanes. This includes PELLETHANE from Dow Chemical Company and its 2363-80 AE grade; K.J. Quin's Q-THANE; B.F. Goodrich's ESTANE; TXIN of Mobay Chemical Company; Commercially available polyurethane compositions such as and the like.

Suitable thermoplastic matrix polymers also include Eastman Chemical, including DuPont's HYTREL and its 4056 grade, and General Electric's LOMOD, both of which are copolymers of polyether prepolymer and polybutylene terephthalate and polyisobutylene terephthalate, respectively. Various polyesters, such as copolymers of various cyclic polyesters, including PCCE. Other suitable polymers include ethylene methacrylic acid and acrylic acid copolymers. For example, ethylene methacrylic acid under the trade name NUCREL 699 is particularly suitable as the thermoplastic matrix polymer.

The various layers of the assemblies 100, 136 of the present invention can be joined by prior art methods to form laminates. One such method involves combining an active agent with a thermoplastic matrix polymer by melt blending to form a polymer layer by extrusion. Another known method is referred to as a solvent-blend method, which forms a mixture using solvating components, coats on a substrate, such as a release liner, and then dries. Melt blending methods are described in more detail in US Pat. No. 6,010,715, the disclosure of which is incorporated herein by reference.

Further, in forming the assemblies 100 and 136 of the present invention, a backing layer, a release layer, an adhesive layer, an activator layer, a pressure-sensitive adhesive layer, an activator permeable adhesive layer, an activator impermeable adhesive layer, an activator impermeable layer, and the like There are several known materials used for the formation of. Suitable materials are disclosed in US Pat. Nos. 5,064,422, 5,123,900, 5,503,844 and 5,948,433, which disclosures are incorporated herein by reference.

8 through 10, an example of a method of manufacturing the assemblies 100, 136 via a solvent-blending method is shown. Referring to assembly 100, active agent layer 122 is formed by mixing a solvated polymer material, such as one having pressure sensitive adhesive properties, with an active agent to be administered to the skin or mucous membranes of a host. The activator polymer mixture is coated onto the release liner, dried, laminated with the activator impermeable backing layer, and wound into a continuous feed roll 160. The release liner is separated from the activator layer and back slit to form a slit, while the activator layer is die cut to the desired size and shape of the inner patch 106. The release liner and activator layer are recombined and the excess activator layer is removed.

In a similar solvent-blending method shown in FIG. 9, the pressure-sensitive adhesive matrix material forming the adhesive layer 110 is coated on a release liner with release properties on both sides, dried and then laminated together with the backing layer, winding To form a feed roll 162. The release liner is removed from the adhesive layer, die cut to form the opening 114, and back slit to form a slit 1200. The release liner is recombined with the adhesive layer and then the waste adhesive layer is removed.

Referring to FIG. 10, the supported activator layer 122 is aligned and mated over the supported adhesive layer 110 and adhered thereto through an opening in the release liner in a continuous process. The release liner for the active agent layer is cut into the appropriate size and shape, and then the outer patch release layer is cut by a guillotine process to form the finished assembly 100.

The description of the method for manufacturing the assemblies 100 and 136 described above with reference to FIGS. 8 to 10 is merely an example. In this regard, other methods of manufacturing assemblies 100 and 136 may be envisioned, and therefore the described methods should not be construed as limiting the scope of the invention.

The present invention is also significantly utilized in connection with a more general application for the handling of laminated adhesive units. For example, referring to FIG. 11, it represents two potential multiplicity of adhesive units, each of which forms a backing layer 172 and an adhesive containing patch or strip coated thereon with adhesive layer 170. 162. Subsequently, a release layer 164 is applied on the adhesive surface of each of these layers. Thus, each of these release layers 164 includes multiple sections 166, 168 that can be separated by a single sheet of material, a laminate of material, or one or more slits 180. When these units are stacked, as in the manufacture of these units, the bottom surface 167 of each of the release layers 164 contacts the top surface of the adhesive layer 170 in each of the adhesive coated layers 162. However, the top surface of each of these release layers 164 also includes a release coating on both portions 166 and 168 thereof, according to the present invention. This layer is in contact with the backing layer 172 in the adhesive containing patch, but all adhesives 170 that pass through the edge of the unit and come into contact with the top surfaces 166, 168 of the release layer 164 are now on the surface. There will be no adhesion, which will stop the manufacturing process if this could occur. In this way, individual units can be prevented from being inappropriately attached to any surface of the release liner. In addition, by carefully selecting the degree of emission on the top and bottom surfaces 167, 166, 168 of the release layer 164, it is possible to clearly control how the units are separated from each other, how much force is required, and the like.

Another example in which the present invention is utilized can be illustrated by considering an intermediate transdermal system manufacturing step of die cutting prior to packaging. It is desirable to die cut each system, but when it is desired to pack these systems in separate operations, the die cutting system can be rewound on a continuous release liner after removing the waste adhesive layer. If the adhesive tends to contact the back side of the continuous release liner of adjacent leaves in the roll, the system may be distorted or damaged when the roll is rewound in subsequent processing steps. The release layer as described above with release agents on both sides prevents adjacent leaves of the roll from adhering to each other.

While the invention has been described above with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the invention. Accordingly, it should be understood that various modifications may be made to the illustrated embodiments, and that other arrangements may be devised without departing from the spirit and scope of the invention as defined by the appended claims.

The present invention provides a transdermal patch system for use in applying an active agent to a patient or host, the system comprising an inner patch and an outer patch containing the active agent and a circular flap containing the active agent completely isolated from the bottom of the patch. do. This makes a system much more efficient than in the prior art for applying all of the active agents.

Claims (31)

An assembly for attaching an adhesive adhesive to a skin or mucous membrane of a host, An outer backing layer including an inner surface and an outer surface, a first adhesive layer provided on the inner surface of the outer backing layer, an inner backing layer, and between the first adhesive layer and the inner backing layer Includes an intermediate release liner, The intermediate release liner includes an inner surface and an outer surface, and both the inner surface and the outer surface of the intermediate release liner include a releasable surface. The method of claim 1, The intermediate release liner comprises one or more open areas, and wherein the first adhesive layer comprises a portion bonded to the inner backing layer in the one or more open areas. The method of claim 1, Wherein said intermediate release liner comprises a single sheet, said single sheet having said releaseable surface on both sides. The method of claim 1, The intermediate release liner comprises a laminate comprising at least one pair of sheets secured to each other, each of the sheet pairs comprising an inner surface and an outer surface, the inner surfaces of the sheet pairs being installed in parallel with each other, the sheet Each outer surface of the pair includes the releaseable surface. The method of claim 1, Wherein said intermediate release liner comprises an activator impermeable material. The method of claim 5, The intermediate release liner is releasably adhered to both the first adhesive layer and the inner backing layer. The method of claim 1, And the first adhesive layer comprises a pressure-sensitive adhesive material for adhering the assembly to the skin or mucous membrane of the host. The method of claim 4, wherein At least one of the pair of sheets comprises a transparent sheet. The method of claim 8, The other of said pair of sheets comprises an opaque sheet. The method of claim 9, An assembly comprising material printed on the inner surface of the other of the pair of sheets. A system for handling a plurality of adhesive-coated elements, A first adhesive coating element comprising an outer backing layer having an inner surface and an outer surface and a first adhesive layer provided on the inner surface of the outer backing layer, A second adhesive coating element comprising an inner surface and an outer surface comprising an inner backing layer, An intermediate release liner installed between the first adhesive layer and the inner backing layer of the second adhesive coating element Including, The intermediate release liner includes an inner surface and an outer surface, and both the inner surface and the outer surface of the intermediate release liner include a releaseable surface. The method of claim 11, The intermediate release liner comprises a single sheet, the single sheet having the releaseable surface on both sides. The method of claim 11, The intermediate release liner comprises a laminate comprising at least one pair of sheets secured to each other, each of the sheet pairs comprising an inner surface and an outer surface, the inner surfaces of the sheet pairs being installed in parallel with each other, the sheet Each outer surface of the pair includes the releaseable surface. The method of claim 11, At least one of the first and second adhesive coating elements is adapted to include an active agent released into the skin or mucous membrane of the host. The method of claim 11, The intermediate release liner comprises an activator impermeable material. The method of claim 11, The intermediate release liner is releasably adhered to both the first adhesive layer and the inner backing layer of the second adhesive coating element. The method of claim 11, And the first adhesive layer comprises a pressure sensitive adhesive material. The method of claim 11, The releaseable surface on the inner surface of the intermediate release liner has a first release force, the releaseable surface on the outer surface of the intermediate release liner has a second release force, and the first and second release forces Are different systems. As stacked multiple of components for preparing an assembly for attaching an adhesive adhesive to the skin or mucosa of a host, A first plurality of outer backing layers comprising an inner surface and an outer surface, A first adhesive layer provided on the inner surfaces of the plurality of outer backing layers, and A second plurality of intermediate release liners including an inner surface and an outer surface Including, Wherein both the inner surface and the outer surface of the plurality of intermediate release liners include a releaseable surface, such that the first plurality of outer backing layers and the second plurality of intermediate release liners can be stacked together without being bonded to each other, A plurality of stacked components. The method of claim 19, Said intermediate release liner comprising a single sheet, said single sheet having said releaseable surface on both sides. The method of claim 19, The intermediate release liner comprises a laminate comprising at least one pair of sheets secured to each other, each of the sheet pairs comprising an inner surface and an outer surface, the inner surfaces of the sheet pairs being installed in parallel with each other, the sheet Each of the outer surfaces of the pair comprising the releasable surface. The method of claim 19, And the pressure sensitive adhesive material for adhering the assembly to the skin or mucous membrane of the host. The method of claim 21, And at least one of the sheet pairs comprises a transparent sheet. The method of claim 23, wherein And the other one of said sheet pairs comprises an opaque sheet. The method of claim 24, A plurality of stacked components comprising a material printed on the inner surface of the other of the pair of sheets. A method for producing an adhesive layer used for preparing an assembly for attaching to the skin or mucous membrane of a host, Coating an adhesive layer on a release liner having a first surface and a second surface, Depositing a backing layer on the first surface of the release liner, Temporarily removing the release liner from the adhesive layer, Die cutting the release liner, and Recombining the release liner with the backing layer Including, Wherein both the first surface and the second surface comprise a releasable surface. The method of claim 26, And wherein said die cutting step includes slitting said release liner into a plurality of release liner portions. The method of claim 27, And the die cutting step includes punching an opening in the release liner. The method of claim 26, Drying the coated release liner. The method of claim 26, Method of producing an adhesive layer comprising the step of removing waste from the adhesive layer. The method of claim 26, Winding the recombined release liner and the backing layer onto a roll.

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